Many patients have reported developing blood clot injuries after using the inferior vena cava (IVC) filter, accusing manufacturing companies of defective product liability. These cage-like devices are placed in the patient’s main vein to stop and prevent blood clots from traveling into the heart and lungs; instead, some of these devices have been accused of doing the opposite of what they are intended to prevent.

According to the FDA, the most common blood clot complications associated with IVC filters include deep venous thrombosis, access site thrombosis, filter migration, and IVC thrombosis. One company is facing heavy legal heat for these and other IVC filter complications, after numerous patients complained of suffering serious blood clots allegedly caused by their IVC filter. This company, Cook Group Inc., regularly faces product liability litigation for various medical devices, including the Celect IVC Filter.

What Is An IVC Filter?

IVC filters are designed to prevent blood clots from moving in the legs, pelvis, heart, or lungs. Blood clots in these vital areas could result in death from pulmonary embolism. When these blood clots become trapped in the IVC filter, these clots will remain in the device until the body naturally breaks them down. While some IVC filters are designed for temporary implantation, others can be permanently placed in the vena cava. The FDA approved the placement of IVC filters in patients suffering from certain thromboembolism conditions, with the agency cautioning patients against long-term use of the device.

This is because IVC filters are intended only for temporary treatments for patients at risk for pulmonary embolism and should be removed once the risk is resolved. Furthermore, the agency cautions physicians to analyze the risks and benefits of the IVC filters and if they would be an ideal solution for the patient.

In 2010, the FDA sent out a public safety announcement regarding the IVC filter complications, stating that 921 adverse reports have been submitted since 2005. In 2014, the FDA updated their initial IVC filter warning by developing a qualitative decision analysis, suggesting that the device should be removed between 29 to 54 days after the blood clot problem is resolved.

Overview of IVC Filter Complications

Cook Group Inc. CEO Pete Yonkman, is concerned with the growing litigation mounting against his company, with a significant portion of the lawsuits against them involving Celect IVC filters. Currently, there are over 100 IVC filter lawsuits filed throughout the federal court system against Cook, claiming that these devices broke apart inside the patient’s vein and then moved through the blood vessel in which the IVC filter had been implanted. Litigation against Cook over faulty IVC filters began in 2012 and has now been consolidated in Indianapolis federal court.

Unfortunately, Cook representatives are expecting more IVC filter lawsuits to be filed, as this company is one of three leading medical companies in this market. According to medical statistics, 200,000 of these blood clot filters are implanted each year in the United States, which is meant to prevent pulmonary embolism. With the popularity of these devices, medical experts predict that numerous injury reports will be submitted to the FDA. However, the Cook IVC filters are noted to be particularly dangerous to medical experts, with one study stating each of the subjects suffered blood clot injuries or that the IVC filter failed to remain in the correct position.

Despite this, Cook representatives state that these IVC filter complications are very rare, and even if they occur, the company is not responsible. The company claims that the prescribing doctors should be experienced and sophisticated enough to recognize the risks of these devices and that patients are also at fault for choosing to have these devices implanted. Even with the company’s stance on product-liability, Cook is eager to resolve these IVC filter lawsuits, as the increasing litigation costs are becoming a financial strain. According to a 2012 analysis by legal experts, it is estimated that legal costs over IVC filter litigation will take up between 1% to 2% of the company’s annual revenue.